Label: PURILAB- citiric acid spray
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Contains inactivated NDC Code(s)
NDC Code(s): 80642-060-01 - Packager: Seoul Food Research & Development Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated October 23, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENTS
- PURPOSE
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WARNINGS
For external use only
When using this product ■ Keep out of eyes. In case of contact with eyes, flush thoroughly with water. ■ Avoid contact with broken skin. ■ Do not inhale or ingest.
Stop use and ask a doctor if skin irritation or rash develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PURILAB
citiric acid sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80642-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 0.13 g in 500 mL Inactive Ingredients Ingredient Name Strength Ascorbic acid (UNII: PQ6CK8PD0R) MALIC ACID (UNII: 817L1N4CKP) ALCOHOL (UNII: 3K9958V90M) Lactic acid (UNII: 33X04XA5AT) SACCHARUM OFFICINARUM WHOLE (UNII: 3Z20C92XNB) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80642-060-01 500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/01/2020 Labeler - Seoul Food Research & Development Co., Ltd. (688787758) Registrant - Seoul Food Research & Development Co., Ltd. (688787758) Establishment Name Address ID/FEI Business Operations Seoul Food Research & Development Co., Ltd. 688787758 manufacture(80642-060)